Robotic surgical systems

ABSTRACT

A robotic surgical system for performing surgery, the system includes a robotic arm having a force and/or torque control sensor coupled to the end-effector and configured to hold a first surgical tool. The robotic system further includes an actuator that includes controlled movement of the robotic arm and/or positioning of the end-effector. The system further includes a tracking detector having optical markers for real time detection of (i) surgical tool position and/or end-effector position and (ii) patient position. The system also includes a feedback system for moving the end effector to a planned trajectory based on the threshold distance between the planned trajectory and the actual trajectory.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is application is a non-provisional application which claimspriority to provisional application Ser. No. 62/411,248 filed on Oct.21, 2016.

BACKGROUND

Robotic-assisted surgical systems have been developed to improvesurgical precision and enable the implementation of new surgicalprocedures. For example, robotic systems have been developed to sense asurgeon's hand movements and translate them to scaled-downmicro-movements and filter out unintentional tremors for precisemicrosurgical techniques in organ transplants, reconstructions, andminimally invasive surgeries. Feedback-controlled robotic systems havealso been developed to provide smoother manipulation of a surgical toolduring a procedure than could be achieved by an unaided surgeon.

However, widespread acceptance of robotic systems by surgeons andhospitals is limited for a variety of reasons. Current systems areexpensive to own and maintain. They often require extensive preoperativesurgical planning prior to use, and they extend the required preparationtime in the operating room. They are physically intrusive, possiblyobscuring portions of a surgeon's field of view and blocking certainareas around the operating table, such that a surgeon and/or surgicalassistants are relegated to one side of the operating table. Currentsystems may also be non-intuitive or otherwise cumbersome to use,particularly for surgeons who have developed a special skill or “feel”for performing certain maneuvers during surgery and who find that suchskill cannot be implemented using the robotic system. Finally, roboticsurgical systems may be vulnerable to malfunction or operator error,despite safety interlocks and power backups.

Spinal surgeries often require precision drilling and placement ofscrews or other implements in relation to the spine, and there may beconstrained access to the vertebrae during surgery that makes suchmaneuvers difficult. Catastrophic damage or death may result fromimproper drilling or maneuvering of the body during spinal surgery, dueto the proximity of the spinal cord and arteries. Common spinal surgicalprocedures include a discectomy for removal of all or part of a disk, aforaminotomy for widening of the opening where nerve roots leave thespinal column, a laminectomy for removal of the lamina or bone spurs inthe back, and spinal fusion for fusing of two vertebrae or vertebralsegments together to eliminate pain caused by movement of the vertebrae.

Spinal surgeries that involve screw placement require preparation ofholes in bone (e.g., vertebral segments) prior to placement of thescrews. Where such procedures are performed manually, in someimplementations, a surgeon judges a drill trajectory for subsequentscrew placement on the basis of pre-operative CT scans. Other manualmethods which do not involve usage of the pre-operative CT scans, suchas fluoroscopy, 3D fluoroscopy or natural landmark-based, may be used todetermine the trajectory for preparing holes in bone prior to placementof the screws. In some implementations, the surgeon holds the drill inhis hand while drilling, and fluoroscopic images are obtained to verifyif the trajectory is correct. Some surgical techniques involve usage ofdifferent tools, such as a pedicle finder or K-wires. Such proceduresrely strongly on the expertise of the surgeon, and there is significantvariation in success rate among different surgeons. Screw misplacementis a common problem in such surgical procedures.

Image-guided spinal surgeries involve optical tracking to aid in screwplacement. However, such procedures are currently performed manually,and surgical tools can be inaccurately positioned despite virtualtracking. A surgeon is required to coordinate his real-world, manualmanipulation of surgical tools using images displayed on a twodimensional screen. Such procedures can be non-intuitive and requiretraining, since the surgeon's eye must constantly scan both the surgicalsite and the screen to confirm alignment. Furthermore, procedural errorcan result in registration inaccuracy of the image-guiding system,rendering it useless, or even misleading. Thus, there is a need for asystem for stabilizing surgical instruments while allowing theinstruments and the instrument holder to be both easily sterilized andinstalled and removed from the robotic system without deterioratinglocalization precision as well as attachment rigidity.

SUMMARY OF THE INVENTION

In an exemplary embodiment, a robotic surgical system includes a roboticarm comprising a force and/or torque control end-effector configured tohold a first surgical tool; an actuator for controlled movement of therobotic arm and/or positioning of the end-effector; a tracking detectorfor real time detection of surgical tool position and/or end-effectorposition and patient position; and a processor and a non-transitorycomputer readable medium storing instructions thereon wherein theinstructions, when executed, cause the processor to: access or generatea virtual representation of a patient situation; obtain a real-timesurgical tool position and/or end-effector position and patient positionfrom the tracking detector; and maintain a surgical instrument along apre-planned trajectory that is stored in the non-transitory computerreadable medium.

In another exemplary embodiment, the instructions, when executed, causethe processor to: determine the instrument is within a thresholddistance of the pre-planned trajectory; and move the robotic arm suchthat the instrument is appropriately aligned with the trajectory.

In another exemplary embodiment, the threshold distance is greater thanzero (e.g., greater than 0.1 cm, 0.5 cm, or 1 cm) and less than 1 meter(e.g., less than 20 cm, 10 cm, 5 cm, 3 cm).

In other embodiments, the surgical robotic system may be used withpre-programmed/pre-planned trajectories and/or surgeries. In oneexemplary embodiment, the robotic surgical system can move automaticallybased on sensor data and artificial intelligence.

BRIEF DESCRIPTION OF THE FIGURES

The foregoing and other objects, aspects, features, and advantages ofthe present disclosure will become more apparent and better understoodby referring to the following description taken in conjunction with theaccompanying drawings, in which:

FIG. 1 is an illustration of drilling a hole using anti-skivingtechnology and drilling a hole without using anti-skiving technology;

FIGS. 2A-2C illustrate a trajectory snap feature;

FIGS. 3A-3C illustrate a universal instrument guide and associatedmethod of use;

FIGS. 4A and 4B illustrate a hole being drilled in bone using real-timecompensation;

FIGS. 5A-5E illustrate robotic guiding of surgical instruments; and

FIG. 6 illustrates a flowchart providing the operational features of theinvention according to one exemplary embodiment.

The features and advantages of the present disclosure will become moreapparent from the detailed description set forth below when taken inconjunction with the drawings, in which like reference charactersidentify corresponding elements throughout. In the drawings, likereference numbers generally indicate identical, functionally similar,and/or structurally similar elements.

DETAILED DESCRIPTION OF THE DRAWINGS

The present application incorporates by reference in its entirety thecontents of U.S. patent application Ser. No. 14/266,769, filed Apr. 30,2014, entitled “Apparatus and Systems for Precise Guidance of SurgicalTools”; U.S. patent application Ser. No. 14/602,627, filed Jan. 22,2015, entitled “Sterile Drape and Adapter for Covering a RoboticSurgical Arm and Preventing Contamination of a Sterile Field”; U.S.patent application Ser. No. 14/695,154, filed Apr. 24, 2015, entitledSurgical Instrument Holder for use with a Robotic Surgical System”; U.S.Patent Application No. 62/395,795, filed Sep. 16, 2016, entitled“Anti-Skid Surgical Instrument for use in Preparing Holes in BoneTissue”; U.S. Patent Application No. 62/278,313, filed Jan. 13, 2016,entitled “Anti-Skid Surgical Instrument for use in Preparing Holes inBone Tissue”; U.S. patent application Ser. No. 14/799,170, filed Jul.14, 2015, entitled “Anti-Skid Surgical Instrument for use in PreparingHoles in Bone Tissue.”

Among other things, the disclosed technology relates to intra-operativeplanning of surgeries using robotic surgical systems and haptic control.Examples of such a system are described in U.S. patent application Ser.No. 14/266,769, filed Apr. 30, 2014, entitled “Apparatus and Systems forPrecise Guidance of Surgical Tools”, the contents of which are herebyincorporated by reference in its entirety.

Furthermore, the disclosed technology includes methods and systems forstabilizing the robotic surgical system on the operation room floor.Additionally, the disclosed technology includes various componentsutilized in or with the robotic surgical system, such as a sterile drapeand an instrument holder. A sterile drape for use with the disclosedtechnology is described in U.S. patent application Ser. No. 14/602,627,filed Jan. 22, 2015, entitled “Sterile Drape and Adapter for Covering aRobotic Surgical Arm and Preventing Contamination of a Sterile Field”,the contents of which are hereby incorporated by reference in itsentirety. An example instrument holder that can be used with thedisclosed technology is described in U.S. patent application Ser. No.14/695,154, filed Apr. 24, 2015, entitled Surgical Instrument Holder foruse with a Robotic Surgical System”, the contents of which are herebyincorporated by reference in its entirety.

The present application relates to robotic surgical systems forassisting surgeons during spinal, neuro, and orthopedic surgery. Thedisclosed technology provides surgeons with the ability to performprecise, cost-effective robotic-assisted surgery. The disclosedtechnology may improve patients' outcome and quality of life as well asreduce the radiation received by the operation room team during surgery.

In one exemplary embodiment, a surgical robotic system provides hapticsteering and force feedback and integrates with existing standardinstruments. In another exemplary embodiment, the surgical system can beintegrated with existing surgical methods, including open, minimallyinvasive, or percutaneous procedures with or without assistance of anavigation system.

FIG. 1 is an illustration of using anti-skiving technology to improvehole placement accuracy. Skiving occurs when drill bit goes off thetrajectory due to drilling at an angle different than the right angle tothe surface. Skiving is a well-known and documented problem for robotsused in surgery, such as spinal surgery. The disclosed technology,including the robot, control system and specially designed drill bit,enables skiving to be practically removed. Examples of this technologyare described in U.S. Patent Application No. 62/395,795, filed Sep. 16,2016, entitled “Anti-Skid Surgical Instrument for use in Preparing Holesin Bone Tissue”, U.S. Patent Application No. 62/278,313, filed Jan. 13,2016, entitled “Anti-Skid Surgical Instrument for use in Preparing Holesin Bone Tissue”, and U.S. patent application Ser. No. 14/799,170, filedJul. 14, 2015, entitled “Anti-Skid Surgical Instrument for use inPreparing Holes in Bone Tissue”, the contents of each of which arehereby incorporated by reference in their entirety. Anti-skiving (alsoreferred to as anti-skid) technology can be used in robotic surgery,with difficult patient anatomy, and for revision surgeries.

The present disclosure provides a surgical robot that includes a roboticarm mounted on a mobile cart. An actuator may move the robotic arm. Therobotic arm may include a force control end-effector configured to holda surgical tool. The robot may be configured to control and/or allowpositioning and/or movement of the end-effector with at least fourdegrees of freedom (e.g., six degrees of freedom, three translations andthree rotations).

In some implementations, the robotic arm is configured to releasablyhold a surgical tool, allowing the surgical tool to be removed andreplaced with a second surgical tool. The system may allow the surgicaltools to be swapped without re-registration, or with automatic orsemi-automatic re-registration of the position of the end-effector.

In some implementations, the surgical system includes a surgical robot,a tracking detector that captures the position of the patient anddifferent components of the surgical robot, and a display screen thatdisplays, for example, real time patient data and/or real time surgicalrobot trajectories.

In some implementations, a tracking detector monitors the location ofpatient and the surgical robot. The tracking detector may be a camera, avideo camera, an infrared detector, field generator and sensors forelectro-magnetic tracking or any other motion detecting apparatus. Insome implementation, based on the patient and robot position, thedisplay screen displays a projected trajectory and/or a proposedtrajectory for the robotic arm of robot from its current location to apatient operation site. By continuously monitoring the patient androbotic arm positions, using tracking detector, the surgical system cancalculate updated trajectories and visually display these trajectorieson display screen to inform and guide surgeons and/or technicians in theoperating room using the surgical robot. In addition, in certainembodiments, the surgical robot may also change its position andautomatically position itself based on trajectories calculated from thereal time patient and robotic arm positions captured using the trackingdetector. For instance, the trajectory of the end-effector can beautomatically adjusted in real time to account for movement of thevertebrae or other part of the patient during the surgical procedure.

Now turning to drawings, FIG. 1 illustrates entry holes created by astandard drill bit and an enhanced drill bit according to one embodimentof the present application. In this exemplary embodiment, an enhanceddrill bit is provided which creates an entry hole 12 that is generallylarger than non-enhanced drill bill. The enhanced drill bit providesanti-skiving features and produces a larger entry hole to minimizeserrors that may occur during surgery causing by skiving.

FIGS. 2A-2C illustrate a surgical robotic system that includes a robotarm 14, and an end effector 16 that is positioned over a patient. In oneembodiment, there is a trajectory “snap” feature that allows optimalpositioning of the end effector 16 on a preferred trajectory. In certainembodiments, a surgeon must move the robotic arm 14 so that the endeffector 16 is near the desired trajectory for the operation. Ratherthan have the surgeon perfectly alight the end-effector with thetrajectory, the robot arm 14 can move the end-effector 16 so that it isappropriately positioned relative to the trajectory once theend-effector is within a threshold distance of the trajectory.

In certain embodiments, once the end-effector 16 is within a thresholddistance of the desired trajectory, the robotic surgical system mayautomatically move (e.g., at a pre-programmed pace) the end effector 16such that the end-effector is appropriately positioned along thetrajectory. The threshold distance can be greater than zero (e.g.,greater than 0.1 cm, 0.5 cm, or 1 cm) and less than 1 meter (e.g., lessthan 20 cm, 10 cm, 5 cm, 3 cm).

In manual surgery, the trajectory has to be found four times: beforeincision, when drilling, when tapping, and when placing screw. Using thedisclosed technology, the trajectory is found once and can be maintainedor a new trajectory may be used. The disclosed technology, in certainembodiments, assists a user in quickly finding trajectories in spaceusing guiding forces (like gravity or virtual spring). Trajectories canalso be planned using navigation techniques and may be downloaded fromnavigation, planned manually, or planned automatically. The surgeon canat any time fine-tune the trajectory using haptic control. This providessignificant potential for time saving in deformity cases.

FIGS. 3A-3C illustrates a surgical robotic system that includes a robotarm 20, and a universal instrument guide 22 and associated methods ofuse. FIG. 3A is an illustration of a drill bit 24 being inserted intothe guide 22 held by the robot arm 20 to drill a hole in a bone.Anti-skiving technology as described above can be used for drilling.Next, as shown in FIG. 3B, a tap 26 is used to prepare/create threads inthe hole. Finally, as shown in FIG. 3C, an instrument 26 is used toplace a screw in the tapped hole. This can be accomplished using thedisclosed technology without the need for a k-wire. Accordingly, a usercan drill, tap and place a screw through the same access channel.

FIGS. 4A and 4B illustrate real-time compensation of the robot arm basedon the tracking of optical markers positioned on instruments during thesurgical procedure. Specifically, real-time compensation allows theinstrument to track the movement of the vertebra. In some situations,the vertebra can move when forces are applied, such as while drilling ahole. In one exemplary embodiment, the robot arm follows the movement ofthe vertebra in real time using navigation techniques.

In one embodiment, as movement of the vertebra is detected and the robotarm automatically adjusts the position of the instrument based on thisdetected movement. This feature allows the planned or set trajectory tobe maintained.

Specifically, FIG. 4A illustrates the vertebra 30 of a patient andtracking device 32 in a first position and the drill 34 in a firstposition. As shown in FIG. 4B, the vertebra 30 has moved to a secondposition and the drill 34 has moved to a corresponding second positionautomatically based on the tracking of the patient and the instruments.This technique can be used in many surgeries, particularly surgeriesthat will encounter highly mobile vertebrae, such as cervical and traumasurgeries. In other embodiments, as the vertebra is moved eitheraccidentally or purposefully, the robotic system automaticallycalculates the movement of the vertebra based on movement andregistration of the tracking device 32. Using the monitored movement ofthe vertebra, the robotic system then automatically causes the robot armto move to the planned trajectory based on the second position of thevertebra.

FIG. 5A illustrates a user planning a trajectory. In one embodiment,there is a robotic arm 40 coupled to a base 42. The robotic arm 40includes an end effector 44 that is configured to receive an instrument46 for performing surgical procedures. A user can move the robotic arm40 with the instrument 46 (e.g., pointer) held by the end-effector 44 toa desired trajectory. The user can then select to have the particulartrajectory saved by within a computer processor of the robotic surgicalsystem. Alternatively, the trajectory can be obtained through real-timenavigation or tracking of the instrument 46 and the patient through theuse of optical markers. As shown in FIG. 5B, in certain embodiments, thevertebra can be punched with an instrument 46 such as an awl. As shownin FIG. 5C, the hole is drilled and tapped to prepare for insertion of ascrew. In certain embodiments, as shown in FIG. 5D, the robot arm is intrajectory-lock mode and follows the advancement of an instrument 46.This can be accomplished by measuring the force applied to theinstrument by the user via a force sensor coupled at the end effectorand moving the robotic arm in accordance with this force. The forcesensor is configured to sense and measure all forces applied to the endeffector. These force sensor is capable of measuring forces in the x, y,and z directions. Next, as shown in FIG. 5E, a screw is placed in thetapped hole. In other embodiments, the instrument 46 may be a drill, atap, k-wire or anything instrument 46 suited to be used for a particularspinal procedure.

FIG. 6 illustrates a flow chart of the feedback system according to oneexemplary embodiment of the present application. A user provides aplanned trajectory 60 for positioning the robot arm and end effectorthrough the use of navigation techniques. In one exemplary embodimentthe planned trajectory is the directional position of the end effectorso that a pedicle screw may be placed in the vertebra. In otherembodiments, the planned trajectory may align the end effector so thatan intervertebral spacer may be positioned through the end effector inthe intervertebral space of adjacent vertebral bodies. In anotherembodiment, the planned trajectory may align the end effector so that abone plate may be positioned on adjacent vertebral bodies. In otherembodiments, the planned trajectory may be a procedure such a biopsy, adiscectomy, bone graft implementation, kyphoplasty, vertebroplasty.

Turning back to FIG. 6, once the planned trajectory is provided to thecomputer system operating the robotic arm, the system continuouslychecks the position of the end effector with planned trajectorypositions and provides a graphical image 64 of the planned positioningof the end effector and the actual positioning of the end effector. Thevariance 66 between the planned trajectory and actual positioning of theend effector and the patient is calculated and imaged to the user. Ifthe variance is less than a threshold distance 68, then robot armremains unmoved from the planned trajectory and the computer systemrechecks the position of the end effector 62 in view of the patient. Ifthe variance is greater than a threshold distance 70, the feedbacksystem will signal the actuator of the robot arm to move the endeffector to the planned trajectory based on the position of the patientand the instruments that are navigated by the optical system. In someembodiments, if the patient is moved accidentally, the thresholdvariance will be greater than the planned trajectory variance and therobot arm will move the end effector to the new trajectory that iswithin the threshold distance. In one exemplary embodiment, thethreshold distance may be greater than 0.1 cm, 0.5 cm, or 1 cm or lessthan 1 meter (less than 20 cm, 10 cm, 5 cm, 3 cm). In certainembodiments, the robotic surgical system continuously checks thethreshold distances in real-time. In other embodiments, the user mayinput a number of reviews of the threshold distances to minimizesrobotic arm movements.

In certain embodiments, the disclosed technology is used for volumeremoval. For example, the disclosed technology can be used fororthopedic surgery, such as unilateral knee replacement. No-go zones,such as locations of nerves and tendons, can be defined before theprocedure is performed. Stay-in zones (volume for implantplacement—“negative” of the implant) can also be defined. A surgeon canmanipulate the robot, directly or remotely, to perform the robot.However, the robot can ensure that the instrument used attached to theend-effector does not enter a no-go zone remains within a stay-in zone.This provides quick and precise implant placement in accordance withplanning. Furthermore, the system can be fully interactive such that thesurgeon remains in control the entire time.

In certain embodiments, the disclosed technology can be used for rodbending. For example, the system can bend rods for use in deformitycases. The system provides quick, easy and automatic rod bending tocreate the appropriately shaped rod. The desired shape can take intoconsideration target sagittal balance and actual pedicle screwplacement. The system can also provide a small bending radius even whenthe rod is formed of the hardest materials. In certain embodiments, therobot is “locked” to particular rods only. The rod bending systemprovides significant time savings and usability improvements.

In view of the structure, functions and apparatus of the systems andmethods described here, in some implementations, a system and method forproviding a robotic surgical system are provided. Having describedcertain implementations of methods and apparatus for supporting anrobotic surgical systems, it will now become apparent to one of skill inthe art that other implementations incorporating the concepts of thedisclosure may be used. Therefore, the disclosure should not be limitedto certain implementations, but rather should be limited only by thespirit and scope of the following claims.

Throughout the description, where apparatus and systems are described ashaving, including, or comprising specific components, or where processesand methods are described as having, including, or comprising specificsteps, it is contemplated that, additionally, there are apparatus, andsystems of the present invention that consist essentially of, or consistof, the recited components, and that there are processes and methodsaccording to the present invention that consist essentially of, orconsist of, the recited processing steps.

It should be understood that the order of steps or order for performingcertain action is immaterial so long as the invention remains operable.Moreover, two or more steps or actions may be conducted simultaneously.

What is claimed is:
 1. A robotic surgical system for performing surgery,the system comprising: a robotic arm comprising a force and/or torquecontrol end-effector configured to hold a first surgical tool; anactuator for controlled movement of the robotic arm and/or positioningof the end-effector; a tracking detector for real time detection of (i)surgical tool position and/or end-effector position and (ii) patientposition; and a processor and a non-transitory computer readable mediumstoring instructions thereon wherein the instructions, when executed,cause the processor to: access or generate a virtual representation of apatient situation; obtain a real-time (i) surgical tool position and/orend-effector position and (ii) patient position from the trackingdetector; and maintain a surgical instrument along a pre-plannedtrajectory that is stored in the non-transitory computer readablemedium.
 2. The system of claim 1, wherein the instructions, whenexecuted, cause the processor to: determine the instrument is within athreshold distance of the pre-planned trajectory; and move the roboticarm such that the instrument is appropriately aligned with thetrajectory.
 3. The system of claim 2, wherein the threshold distance isgreater than zero and less than 20 cm.
 4. The system of claim 2, whereinthe threshold distance greater than 0.1 cm and less than 20 cm.
 5. Thesystem of claim 2, wherein the threshold distance is greater than 1 cmand less than 3 cm.
 6. The system of claim 2, wherein the thresholddistance is greater than 0.5 cm and less than 5 cm.
 7. The system ofclaim 1, wherein the end effector is configured to receive a secondsurgical tool for performing surgical procedures.
 8. The system of claim1, wherein the first surgical tool is a drill bit.
 9. The system ofclaim 1, wherein the first surgical tool is an awl.
 10. The system ofclaim 1, wherein the first surgical tool is used to position a pediclescrew in bone.
 11. The system of claim 1, wherein the first surgicaltool includes optimal markers.
 12. A robotic surgical system forperforming surgery, the system comprising: a robotic arm comprising aforce and/or torque control end-effector configured to hold a firstsurgical tool; an actuator for controlled movement of the robotic armand/or positioning of the end-effector; a tracking detector includingoptical markers for real time detection of (i) surgical tool positionand/or end-effector position and (ii) patient position; and a feedbacksystem for moving the end effector to a planned trajectory based on athreshold distance.
 13. The system of claim 12, wherein the feedbacksystem, includes a force sensor that calculates the movement of the endeffector away from the planned trajectory a threshold distance and movesthe robotic arm such that the first surgical tool is aligned with theplanned trajectory.
 14. The system of claim 12, wherein the thresholddistance is greater than zero and less than 20 cm.
 15. The system ofclaim 12, wherein the threshold distance greater than 0.1 cm and lessthan 20 cm.
 16. The system of claim 12, wherein the threshold distanceis greater than 1 cm and less than 3 cm.
 17. The system of claim 12,wherein the threshold distance is greater than 0.5 cm and less than 5cm.
 18. A robotic surgical system comprising: a robotic arm; an endeffector coupled to the robotic arm; an tracking system for trackingmarkers positioned on the end effector and a patient; a feedback systemconfigured to move the robot arm based on the position of the endeffector with reference to the patient. wherein the feedback systemgenerates a first position value that is defined by a tracked positionof a planned trajectory for performing a surgical procedure and a secondposition value that is the tracked position of the actual position ofthe patient with reference to the end effector.
 19. The robotic surgicalsystem of claim 18, wherein the difference between the first positionvalue and the second position value is compared to a threshold variance.20. The robotic surgical system of claim 19, wherein the robotic arm ismoved based on whether the difference between the first and the secondposition value and the threshold variance.